Quick Facts at a Glance
- Recall Date
- January 7, 2026
- Hazard Level
- HIGH
- Brand
- Olympus Corporation of the Americas
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Olympus Corporation of the Americas
- Product type
- Sphincterotome
- Model numbers
- Model/Catalog Number: KD-VC411Q-0730, Material REF: (1) N5391330, (2) N5391310, (3) N5777630, UDI-DI: (1) 04953170399329, (2) 04953170399329, (3) 04953170399329, All Lots with a valid expiration date
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
January 7, 2026
Reported by FDA DEVICE
February 11, 2026
RecallRadar source check
April 13, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Devices which did not undergo thermoforming could deform and lose performance.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Olympus Corporation of the Americas or your healthcare provider for instructions. Notification method: Letter
About This Product
The Single Use 3-Lumen Sphincterotome V is utilized in medical procedures for papillotomy. Healthcare providers use this device to assist in the removal of bile stones or to perform other therapeutic interventions.
Why This Is Dangerous
The potential for deformation occurs when the devices do not undergo necessary thermoforming, which can compromise the structural integrity and performance of the device during critical medical procedures.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall presents serious safety concerns for patients as the malfunction of these devices could lead to inadequate treatment during medical procedures.
Practical Guidance
How to identify if yours is affected
- Check the model number KD-VC411Q-0730 on the product packaging.
- Verify any product lot numbers against the recall announcement.
- Consult your healthcare provider if unsure about your device.
Where to find product info
The model number can typically be found on the device packaging or instruction manual.
What timeline to expect
Expect a refund or replacement processing time of 4 to 8 weeks once the returned device is received by Olympus.
If the manufacturer is unresponsive
- Contact Olympus customer service again for follow-up.
- Document all correspondence and maintain a record of your requests.
How to prevent similar issues
- Always check for recalls before using medical devices.
- Look for FDA clearance and certifications on medical equipment.
Documentation advice
Keep records of receipts, communication with Olympus, and any medical records related to the use of the device.
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Product Details
The recalled product is the Single Use 3-Lumen Sphincterotome V, Model/Catalog Number KD-VC411Q-0730. These devices are designed for use with an Olympus endoscope and guidewire for papillotomy. The devices were distributed worldwide, with 10,257 units recalled, including 274 in the U.S.
Key Facts
- Recall Date: January 7, 2026
- Report Date: February 11, 2026
- Quantity Recalled: 10,257 units
- Hazard Level: High
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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